1. Field of the Invention
The present invention relates to a sealing device for sealing externally debouching, natural or artificial body canals of animals or human beings, the device enabling liquid tight sealing against the inner wall of the bowel system of the animal or human being, especially when performing irrigation through a natural or artificial body opening of the animal or human being. The invention further relates to the use of such a device.
The device is especially suitable as a sealing member incorporated with a disposable trans-anal or trans-stomal irrigation probe.
Faecal continence can be defined as the ability to control defecation, to be able to distinguish flatus from loose respectively formed faeces or to be able to maintain faecal continence even during sleep without use of external aids. In the bowel system the nerves and muscles of the colon, rectum and anus function together in a closely co-ordinated manner in order to maintain continence. In case of any malfunction e.g. if a person is suffering from some kind of defect in the control of the bowel, this person will very likely be incontinent. The defects may e.g. occur as result of a spinal cord injury, multiple sclerosis (MS), tumours or metastases, diabetes, spina bifida or ideopatic constipation.
In addition to surgical treatment of faecal incontinence, medication and regulating nutrition, meal times and defecation habits, enemas or irrigation are some of the treatments that have been practised for long time. Enemas or irrigation may also be used by completely healthy people if they for some reason want a colonic lavage.
2. Description of the Related Art
For these purposes several devices have been proposed in the past. In addition to devices especially for use of performing irrigation for treatment of incontinence, other similar devices have been proposed for irrigation, e.g. products developed for administration of barium sulphate enema or the like as part of a radiological examination.
One example of a prior art device is disclosed in U.S. Pat. No. 3,459,175. The device includes an inflatable balloon for giving enemata. The balloon is located on the probe for introduction of irrigation liquid, and the balloon is to be inflated when positioned in the rectum of the patient close to the anal opening. The ballooned annular element thereby blocks for undesired flow from the bowel through anus.
However, existing enemata probe sealings of the type provided with inflatable balloons inherently possess a number of disadvantages.
To ensure a sufficiently tight sealing to be obtained when placed in the bowel system, the balloon is often inflated to a greater size than necessary thereby exerting an excessive pressure on the bowel wall and even on a larger surface than intended or necessary. Furthermore, all known products on the market have relatively hard and incompressible balloons. This is likely to induce refectory contraction of the muscles in the bowel and the lower part of colon, resulting in the enemata probe being forced out through the anal opening. Further to the unpleasant leakage, as a result of such premature displacement of the probe with the balloon still being inflated may cause serious injury to the fragile wall of rectum. Also, when expanding in axial direction the balloon may be brought to cover the openings of the probe, thus stopping the intended flow of liquid into the bowel system. Furthermore, there is a risk that a balloon may be overfilled and may result in a rupture of the balloon. Such a situation may likewise cause damage of the fragile wall of the rectum, leakage of the liquid filled content of the colon sigmoideum and rectum and stress of the patient. Also, the balloon may leak which will let the air of the balloon leak out. As a result of this, the device suddenly may fall out of the rectum followed by an unintended leakage of faecal matter. As the users of enemata probes may have no sensory function in the rectum they may not themselves immediately register if the device is falling out. Finally, balloons used in these devices are often made from latex. This may cause problems for patients and others suffering from latex allergy.
When having to perform irrigation on small children another problem may arise as the devices commercially available today are rather large, they therefore seem relatively scaring both for the small children and for their parents.
Another disadvantage in connection with the mentioned products are that they are too expensive to be used as disposable products. According to specialists these products are used several times for the same patient, while being cleaned in-between uses. Apart from being time consuming due to necessary cleaning steps it will be understood that the risk of contaminating the environment during storage of the product in between each use and the risk of infecting the user is much bigger than compared to the risk when using disposable products.
A disposable kit for trans-anal irrigation is described in WO 98/23312. The kit comprises a container for irrigation media and is connected to a catheter or probe through which the enemata liquid is administered into the bowel system. The probe is provided with a fixation member intended to ensure fixation of the probe inside the bowel system during inlet of the enemata liquid. The fixation member is made from a compressible material such as a foam or a moulded elastic material. The fixation member is provided in a compressed state and surrounded by a PVA film which will dissolve when getting into contact with humidity. The fixation member is as an example made of a polyurethane and has an open structure to allow for air passing through during irrigation. Using a foam material secures a lenient contact between the bowel wall and fixation member of the probe, and the open structure favourably enhances compressibility of the fixation member but has proved to imply the disadvantage of permeability for fluids during irrigation leading to undesired leakage of irrigation media and liquid bowel contents.
It is an object of the invention to provide a soft and compressible sealing device for providing liquid tight sealing properties in order to overcome the above mentioned disadvantages of sealing devices and avoiding leakage, especially avoiding triggering of the analreflex thus expulsing the device.